Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 3,401–3,450 of 7,959

• Medical Device Recall · April 10, 2025

  Contec Medical Systems Co., Ltd.

  CMS8000 Patient Monitor

  Patient monitor has nine identified cybersecurity vulnerabilities.

  Class II

• Medical Device Recall · April 10, 2025

  Vyaire Medical

  Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-h

  Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

  Class I

• Medical Device Recall · April 10, 2025

  Smiths Medical ASD, Inc.

  CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21

  Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

  Class I

• Medical Device Recall · April 10, 2025

  Smiths Medical ASD, Inc.

  CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLI

  Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

  Class I

• Medical Device Recall · April 10, 2025

  Vyaire Medical

  Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat,

  Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

  Class I

• Medical Device Recall · April 10, 2025

  Smiths Medical ASD, Inc.

  CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA E

  There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

  Class I

• Medical Device Recall · April 10, 2025

  Smiths Medical ASD, Inc.

  CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/

  There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

  Class I

• Medical Device Recall · April 10, 2025

  Smiths Medical ASD, Inc.

  CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HP

  Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

  Class I

• Medical Device Recall · April 9, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395

  Three is the potential for the retractors to puncture through the sterile packaging.

  Class II

• Medical Device Recall · April 9, 2025

  Foundation Medicine, Inc.

  FoundationOne Companion Diagnostic (F1CDx)

  Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

  Class II

• Medical Device Recall · April 9, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Centurion Sterile Weitlaner Retractor, Reorder: 67315

  Three is the potential for the retractors to puncture through the sterile packaging.

  Class II

• Medical Device Recall · April 9, 2025

  Richard Wolf GmbH

  PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

  The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

  Class II

• Medical Device Recall · April 8, 2025

  Beckman Coulter Inc.

  REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info

  Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.

  Class II

• Medical Device Recall · April 8, 2025

  Inari Medical - Oak Canyon

  Artix MT Thrombectomy Device, REF: 32-102

  Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

  Class II

• Medical Device Recall · April 7, 2025

  Baxter Healthcare Corporation

  Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

  A cybersecurity vulnerability was discovered through internal testing.

  Class I

• Medical Device Recall · April 7, 2025

  Baxter Healthcare Corporation

  Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.

  A cybersecurity vulnerability was discovered through internal testing.

  Class I

• Medical Device Recall · April 7, 2025

  Apic Yamada America

  Molding Equipment. WCM series. Model WCM-330GL-i

  Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.

  Class II

• Medical Device Recall · April 7, 2025

  Ambu Inc.

  Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

  Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.

  Class II

• Medical Device Recall · April 7, 2025

  Philips Medical Systems Nederland B.V.

  IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

  An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

  Class II

• Medical Device Recall · April 7, 2025

  SCIENCE & BIO MATERIALS

  Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

  Vials of implant bone granules may contain less product then specified on labeling.

  Class II

• Medical Device Recall · April 7, 2025

  Philips North America Llc

  Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2

  Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

  Class II

• Medical Device Recall · April 4, 2025

  Micro-X Ltd.

  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-conta

  Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

  Class II

• Medical Device Recall · April 4, 2025

  Integra LifeSciences Corp. (NeuroSciences)

  INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

  Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

  Class II

• Medical Device Recall · April 4, 2025

  Olympus Corporation of the Americas

  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to

  Preset treatment parameters are not consistently being used in accordance with the IFU.

  Class II

• Medical Device Recall · April 4, 2025

  Micro-X Ltd.

  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a

  Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

  Class II

• Medical Device Recall · April 4, 2025

  Klinika Mdical Gmb

  KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of

  Potential for microbial contamination.

  Class II

• Medical Device Recall · April 4, 2025

  Klinika Mdical Gmb

  KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording

  Potential for microbial contamination.

  Class II

• Medical Device Recall · April 3, 2025

  WANDERCRAFT SAS

  Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator

  Potential for exoskeleton to lose lateral balance and cause patient to fall.

  Class II

• Medical Device Recall · April 3, 2025

  Globus Medical, Inc.

  MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

  Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

  Class II

• Medical Device Recall · April 3, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5)

  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  Class II

• Medical Device Recall · April 3, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5)

  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  Class II

• Medical Device Recall · April 3, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-

  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  Class II

• Medical Device Recall · April 3, 2025

  Medtronic Neuromodulation

  Enhanced Verify Evaluation Handset (CFN HH90130FA)

  Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

  Class II

• Medical Device Recall · April 3, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 88

  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  Class II

• Medical Device Recall · April 2, 2025

  Preat Corp

  Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arc

  Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

  Class II

• Medical Device Recall · April 2, 2025

  Leica Biosystems Melbourne Pty Ltd

  HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tis

  There is a leakage issue associated with the tubing in the manifold of the instrument.

  Class II

• Medical Device Recall · April 2, 2025

  Getinge Disinfection Ab

  Washer Disinfector Aquadis 56; Model Number: 56M

  The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

  Class II

• Medical Device Recall · April 2, 2025

  Getinge Disinfection Ab

  Washer Disinfector Aquadis 56; Model Number: 56A

  The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

  Class II

• Medical Device Recall · April 1, 2025

  IBA Dosimetry GmbH

  myQA iON; Article Number: MQ10-000;

  Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

  Class II

• Medical Device Recall · April 1, 2025

  Philips North America Llc

  Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

  Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

  Class II

• Medical Device Recall · March 31, 2025

  Belmont Instrument LLC

  3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). Th

  Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

  Class II

• Medical Device Recall · March 31, 2025

  Belmont Instrument LLC

  Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-0

  Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

  Class II

• Medical Device Recall · March 31, 2025

  AVID Medical, Inc.

  Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

  An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

  Class II

• Medical Device Recall · March 31, 2025

  AVID Medical, Inc.

  Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.

  An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

  Class II

• Medical Device Recall · March 31, 2025

  AVID Medical, Inc.

  Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

  An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

  Class II

• Medical Device Recall · March 31, 2025

  Siemens Healthcare Diagnostics Inc

  Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

  Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

  Class II

• Medical Device Recall · March 31, 2025

  Belmont Instrument LLC

  Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-0003

  Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

  Class II

• Medical Device Recall · March 31, 2025

  Ultra Clean Systems, Inc.

  Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system

  During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

  Class II

• Medical Device Recall · March 31, 2025

  Belmont Instrument LLC

  Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Lite

  Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

  Class II

• Medical Device Recall · March 28, 2025

  Micro-X Ltd.

  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-cont

  Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

  Class II